NCT06457516

Brief Summary

A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 10, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • BBS (berg balance scale)

    A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke.

    6 Month

  • FGA (functional gait assessment scale)

    The normal score on the FGA would be considered \>27/30; for adults from ages 60 to 80 years, the normal score on the FGA would be considered \>24/30; and for adults over the age of 80 years, the normal score would be considered \>19/30

    6 Months

Study Arms (2)

Mirror Therapy

EXPERIMENTAL
Combination Product: Mirror Therapy

Music Therapy

OTHER
Other: Music Therapy

Interventions

Mirror TherapyCOMBINATION_PRODUCT

A mirror is used to create a reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain, or to create positive visual feedback of a limb movement. It involves placing the affected limb behind a mirror.

Mirror Therapy

Music therapy, an allied health profession, the clinical and evidence-based use of music interventions to accomplish individualized goals

Music Therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ischemic and hemorrhagic post stroke hemiplegic patients
  • patients of age 40-60 years
  • no visual perception dysfunction

You may not qualify if:

  • patients with fracture of upper or lower limb
  • patient with comorbidities
  • patients with hearing issues
  • patients with cognitive disabilities
  • patient with other neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaudhary Muhammad Akram Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Mirror Movement TherapyMusic Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsSensory Art TherapiesComplementary TherapiesAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

September 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations